MAUDE Adverse Event Report: STERIS CORPORATION HARMONYAIR; HARMONYAIR MONITOR CARRIER

Model Number	MONITOR CARRIER
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite following the event to inspect the harmonyair monitor carrier.During the technician's inspection he found that the rotational stop which is part of the bearing system was broken.The technician further observed that the top brake wires and control board were damaged.The internal hoses/cables inside the boom were also damaged which may be attributed to the hoses/cables being stretched and tangled from the monitor carriers arm's being over rotated.The technician repaired the unit, tested the function and operation and returned the unit to service.The harmonyair monitor carrier subject of the reported event is not under steris service contract for preventive maintenance; the user facility is responsible for maintenance activities.A complaint review confirmed this to be an isolated event.No additional issues have been reported.
Event or Problem Description
The user facility reported that during a patient procedure a "metal bearing" fell from their harmonyair monitor carrier into the sterile field.The sterile field was reestablished, and the procedure was completed successfully following a delay.No report of injury.

• Brand Name: HARMONYAIR
• Common Device Name: HARMONYAIR MONITOR CARRIER
• Manufacturer (Section D): STERIS CORPORATION; 2720 gunter park drive east; montgomery AL 36109
• Manufacturer (Section G): STERIS CORPORATION; 2720 gunter park drive east; montgomery AL 36109
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060
• MDR Report Key: 21551733
• Report Number: 1043572-2025-00028
• Device Sequence Number: 8175660
• Product Code: FQO
• UDI-Device Identifier: 00724995153359
• UDI-Public: (01)00724995153359(11)220829
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/07/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MONITOR CARRIER
• Device Catalogue Number: HCLP120001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2025
• Initial Report FDA Received Date: 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown